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  1. 1

    المصدر: Diabetes technologytherapeutics. 19(2)

    الوصف: Literature supports short-term efficacy and safety of Sensor Augmented Insulin Pump (SAP) therapy in patients with type 1 diabetes (T1D). However, no data are available showing long-term outcomes. Our study describes the long-term outcomes of SAP therapy with low-glucose suspend feature (SAP+LGS) in hypoglycemia in a Colombian population with T1D and hypoglycemia.A cohort study was conducted with T1D patients receiving SAP+LGS therapy who initiated this therapy because of hypoglycemia at San Ignacio University Hospital diabetes center in Bogotá, Colombia. Glycated hemoglobin (A1c) was assessed at least every 6 months, severe hypoglycemia (SH) and hypoglycemia unawareness (HU) incidence yearly. Adherence to therapy was also evaluated.One hundred eleven patients were included in the analysis. Total daily insulin dose was reduced during follow-up (mean difference -0.22 U/kg; 95% confidence interval [CI] -0.18 to -0.26; P 0.001). A1c levels were reduced from a baseline value of 8.8% ± 1.9% to 7.5% ± 1.0% at 5 months (mean difference -1.3%; 95% CI -1.09 to -1.50; P 0.001) and 7.1% ± 0.8% (mean difference -1.7%; 95% CI -1.59 to -1.90; P 0.001) at the end of follow-up (47 months on average). The incidence of SH and HU episodes decreased significantly since the first year, and this effect was maintained over time (P 0.001).SAP+LGS therapy in T1D patients with hypoglycemia led to a significant and sustained decrease in A1c during long periods of follow-up, as well as a significant reduction in SH and HU. Future randomized clinical trials are desired.

  2. 2

    المصدر: Diabetes technologytherapeutics. 17(6)

    الوصف: ntroduction: The ProAct study has shown that a pump switch to the Accu-Chek® Combo system (Roche Diagnostics Deutschland GmbH, Mannheim, Germany) in type 1 diabetes patients results in stable glycemic control with significant improvements in glycated hemoglobin (HbA1c) in patients with unsatisfactory baseline HbA1c and shorter pump usage time. Patients and Methods: In this post hoc analysis of the ProAct database, we investigated the glycemic control and glycemic variability at baseline by determination of several established parameters and scores (HbA1c, hypoglycemia frequency, J-score, Hypoglycemia and Hyperglycemia Indexes, and Index of Glycemic Control) in participants with different daily bolus and blood glucose measurement frequencies (less than four day, four or five per day, and more than five per day, in both cases). The data were derived from up to 299 patients (172 females, 127 males; age [mean±SD], 39.4±15.2 years; pump treatment duration, 7.0±5.2 years). Results: Participants with frequent glucose readings had better glycemic control than those with few readings (more than five readings per day vs. less than four readings per day: HbA1c, 7.2±1.1% vs. 8.0±0.9%; mean daily blood glucose, 151±22 mg/dL vs. 176±30 mg/dL; percentage of readings per month >300 mg/dL, 10±4% vs. 14±5%; percentage of readings in target range [80-180 mg/dL], 59% vs. 48% [P

  3. 3

    المصدر: Diabetes technologytherapeutics. 17(1)

    الوصف: Continuous subcutaneous insulin infusion (CSII) is an effective method of intensive therapy for patients with type 1 diabetes; however, most studies have not examined long-term glycemic control. We evaluated the long-term efficacy of CSII in a cohort of adult patients with type 1 diabetes.This was a retrospective observational study of 200 patients with type 1 diabetes who initiated CSII at a single outpatient clinic in Kingston, ON, Canada between January 1998 and December 2012. Data were collected from 3 months prior to and up to 15 years after initiation of CSII and included glycated hemoglobin (HbA1c) level and demographic factors potentially associated with glycemic control.Mean age and duration of diabetes at CSII initiation were 35.4 years and 22.4 years, respectively. Mean duration of CSII at the time of analysis was 6 years. Mean HbA1c at initiation of CSII was 8.7% and decreased to a nadir of 7.5% 6 months post-initiation (SD = 1.0) (P0.001). This increased over time (range, 7.8-8.2%) but remained lower than the pre-CSII HbA1c (P0.001). Shorter duration of diabetes prior to CSII initiation, history of missed appointments, mental illness, and active smoking were predictors of higher HbA1c on CSII. Pre-CSII HbA1c predicted long-term HbA1c on CSII.The data demonstrate that in a clinic setting, patients on CSII maintain lower HbA1c values over a 1-10-year period compared with pre-CSII values. Poor pre-CSII HbA1c, history of missed appointments, mental illness, and active smoking are predictors of those less likely to achieve an HbA1c target of ≤ 7.0%.

  4. 4

    المصدر: Diabetes technologytherapeutics. 16(5)

    الوصف: This study determined the association of continuous glucose monitoring glucose (CGM-glucose) levels at different times of the day with improvement in glycated hemoglobin (HbA1c) levels. The potential application of these data is to focus effort to improve glucose control in patients with type 1 diabetes.Data were analyzed from 196 patients with type 1 diabetes who were randomized to receive sensor-augmented pump therapy in the 1-year STAR 3 trial. CGM-glucose values and HbA1c levels from baseline and after 1 year were evaluated to determine associations of improvement in CGM-glucose at different times of the day with longitudinal improvement in HbA1c.Improvement in HbA1c levels after 1 year was related to improvement in mean CGM-glucose levels in daytime (6 a.m.-midnight), overnight (midnight-6 a.m.), and each mealtime period (P0.0001 for each). In multivariable analysis, only improvement in breakfast meal period was associated with improvement in HbA1c after 1 year, explaining 59% of the HbA1c improvement using the partial R(2) test. Moreover, among those patients who only improved CGM-glucose in the overnight period there was an associated improvement in breakfast meal period CGM-glucose of 26 ± 22 mg/dL (P0.01).Breakfast period glucose improvement had the greatest effect on lowering HbA1c levels in patients with type 1 diabetes. Improving glucose control overnight resulted in subsequent improvement in the breakfast period. Although glucose control should be improved at all times, methods to improve overnight and post-breakfast glucose levels may be of primary importance in improving glucose control in patients with type 1 diabetes.

  5. 5

    المصدر: Diabetes technologytherapeutics. 18(3)

    الوصف: Carbohydrate estimation and bolus calculation are two important skills for handling intensive insulin therapy and effectively using bolus calculators. Structured assessment of both skills is lacking. A new tool for the assessment of skills in carbohydrate estimation and bolus calculation was developed and evaluated.A new assessment tool (SMART) was developed that included 10 items for bolus calculation and 12 items for carbohydrate estimation. In total, 411 patients on intensive insulin treatment were recruited. Different parameters of glycemic control were used as validity criteria.The SMART tool achieved good reliability for the assessment of bolus calculation (Cronbach's α = 0.78) and sufficient reliability for the assessment of carbohydrate estimation (Cronbach's α = 0.67). A good bolus calculation skill was significantly associated with lower glycated hemoglobin values (r = -0.27), lower mean blood glucose levels (r = -0.29), and higher fluctuation of blood glucose control (r = -0.43). A good carbohydrate estimation skill was significantly associated with a lower frequency of severe hyperglycemia (r = -0.27) and a higher frequency of euglycemia (r = 0.26).SMART is a reliable and valid tool for the assessment of both skills. Bolus calculation as well as carbohydrate estimation was associated with glycemic control. With the help of SMART, important skills for the management of intensive insulin therapy can be assessed separately. Thus, in clinical practice patients in need of assistance from a bolus calculator can be identified.

  6. 6

    المصدر: Diabetes technologytherapeutics. 13(12)

    الوصف: The aim of this study was to evaluate the influence of physical activity on blood glucose, insulinemia, and ketone bodies level during interruption of insulin delivery.We enrolled 12 patients with type 1 diabetes (men with an average age of 33.4±8.66 years, body mass index of 25.7±3.75 mg/m(2), and glycated hemoglobin of 8.4±0.95%). The test was performed after overnight fasting at the usual insulin dosage. The delivery of insulin by the pump was stopped for 3 h, and blood samples were obtained in 30-min intervals for determination of blood glucose, insulinemia, β-hydroxybutyrate, non-esterified fatty acids, and acid-base balance parameters. A test with (EXE) or without (CON) physical exercise (moderate aerobic exercise) was performed in each patient at random in the course of 2 weeks. Results are presented as median (first quartile; third quartile).Groups CON and EXE did not differ in blood levels of insulin during the test. Regarding time course of glycemia, we found differences only in min 270 for CON versus EXE of 15.2 (13.6; 16.7) and 13.9 (9.1;16.5) mmol/L, respectively (P=0.038). Concerning blood levels of β-hydroxybutyrate, we found significant differences in min 180-300 of the test: CON of 419 (354; 541), 485 (344; 580), and 107 (63; 156) μmol/L versus EXE of 690 (631; 723), 703 (562; 871), and 241 (113; 507) μmol/L (P0.01). Comparable results were found in values of total ketone bodies and free fatty acids.The influence of physical activity during a 3-h interruption of insulin pump treatment is evident, especially in the increase in plasma levels of non-esterified fatty acids and ketone bodies. Correction bolus leads to a rapid increase in insulinemia; however, normalization of blood glucose and ketone bodies is achieved within another 90 min.

  7. 7

    المصدر: Diabetes Technology & Therapeutics
    r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
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    الوصف: Aims: This study compared glycemic control and maternal and fetal outcomes in pregnant women with type 1 diabetes mellitus (T1DM) treated with multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII) using regular (RI) or lispro (LP) insulin. Methods: Three hundred fifteen consecutive singleton pregnancies of T1DM women using the same insulin program since before pregnancy (196 MDI with NPH + RI, 16 MDI with NPH + LP, 44 CSII with RI, 59 CSII with LP) were studied. Variables of glycemic control assessed included glycated hemoglobin, mean blood glucose (MBG), and insulin doses in each trimester, diabetic ketoacidosis, and hypoglycemic comas. Variables of pregnancy outcome included miscarriage, preterm birth, large or small for gestational age (LGA or SGA, respectively) newborns, and perinatal mortality. Multiple linear regression and logistic regression analysis were used. Results: Groups differed in baseline and glycemic control but not in maternal or fetal outcomes. In multivariate analysis, LP was associated with higher second trimester MBG and lower rate of hypoglycemic coma, CSII with higher third trimester MBG, and CSII + LP with lower insulin requirements and lower rate of hypoglycemic coma. As to pregnancy outcomes, LP was associated with lower risk of preterm birth and higher risk of SGA, CSII with lower risk of SGA and higher risk of LGA and perinatal mortality, and CSII + LP with higher risk of miscarriage. Conclusions: Pregnant women with T1DM using LP and/or CSII had different characteristics. LP with or without CSII was independently associated with fewer hypoglycemic comas, whereas impact of LP/CSII on the fetus had a favorable or an unfavorable influence depending on the specific outcome.

  8. 8

    المصدر: Diabetes technologytherapeutics. 5(4)

    الوصف: Continuous glucose monitoring allows patients with diabetes to check their metabolic status throughout the day, including rarely monitored time periods, such as postprandial and nocturnal periods. The performance of a prototype of the novel SCGM1 System (Roche Diagnostics GmbH, Mannheim, Germany) employing the microdialysis technique was evaluated. Forty-two patients with type 1 diabetes participated in the study [29 males/13 females, age 34 +/- 9 years, duration of diabetes 16 +/- 11 years, glycated hemoglobin 7.7 +/- 1.2% (mean +/- SD)]. Forty-seven experiments were performed at four different investigational sites. A microdialysis catheter was inserted into the subcutaneous tissue of the patient's abdominal wall. Glucose was extracted from the interstitial fluid, and glucose levels were determined and stored by the SCGM1 System continuously for the duration of the experiment. Capillary blood glucose was measured frequently (at least 10 times per day) and used for linear retrospective calibration. The patients were instructed to maintain their normal diet and insulin therapy. Thirty experiments (mean duration 103 +/- 18 h) were analyzed in detail. The mean deviation of the calibrated glucose sensor values from the capillary blood glucose values (expressed as percent predicted error sum of squares) was

  9. 9

    المصدر: Diabetes technologytherapeutics. 12(5)

    الوصف: Recently, many patients with Kir6.2-related permanent neonatal diabetes mellitus (PNDM) have been successfully transferred from insulin therapy to sulfonylurea (SU) treatment. The long-term efficacy and safety of SU treatment in PNDM patients, however, have not yet been determined.We monitored glycemic control and the occurrence of potential side effects in 14 Kir6.2-related PNDM patients from Poland (median age, 12.0 years; range, 5-50 years) who were transferred to SU therapy at least 2 years ago. Three of the 14 patients were lost to follow-up, whereas for the remaining 11 individuals the median follow-up was 34 months (range, 27-51 months).The initial reduction of glycated hemoglobin (HbA1c) after the switch to SU (approximately 3-6 months post-transfer) was 1.68% (range, 0.3-3.7%), and good metabolic control was maintained over the entire period of observation with an average HbA1c level of 6.0% (range, 5.3-6.7%) at the last visit. This was accompanied by a substantial drop in SU dose by 0.24 mg/kg, which constituted a 38.0% decrease. A rapid progression of retinal changes was observed in one patient, a 34-year-old woman at the beginning of the observation, with preexisting proliferative diabetic retinopathy. No causal relationship between these changes and SU treatment could be proven. Neither serious side effects nor progression of diabetes complications was observed in any other patients. No detrimental effect on growth in the observed minors was recorded.In summary, the switch from insulin therapy to SU treatment in PNDM related to KCNJ11 mutations was found to be an efficient and safe therapeutic method over a period of 34-month median follow-up. Although no serious side effects were associated with SU treatment, their use in Kir6.2 PNDM requires further attention, particularly in children, adolescents, and patients with advanced chronic diabetes complications.